[This Transcript is Unedited]
Department of Health and Human Services
National Committee on Vital and Health Statistics
Subcommittee on Standards
June 16, 2010
Sheraton Crystal City Hotel
1800 Jefferson Davis Highway
Arlington, VA
Proceedings by:
CASET Associates, Ltd.
Fairfax, Virginia 22030
(703) 266 8402
P R O C E E D I N G S
DR. WARREN: Am I on now? Great so why don’t we get started. We have had a little confusion of coordination here. Staff gave you a packet that has our agenda on it and then a printout of the slides that we are also showing and then a schedule of hearings for our July hearings. Then I just handed around another set of slides that are smaller so you might want the bigger slides, they are easier to read and then a document that Walter and I worked on for strategic planning. So with that we need to quickly introduce ourselves and do our conflict of interest thing.
I am Judith Warren, University of Kansas School of Nursing and am Co-Chair of the Standards Subcommittee and I have no conflicts. Walter?
DR. SUAREZ: Yes, I am Walter Suarez with Kaiser Permanente. I am a new Co-Chair of the Standards Subcommittee and I don’t have any conflicts.
DR. CARR: Justine Carr, Caritas Christi, no conflicts.
MR. REYNOLDS: Harry Reynolds, IBM, no conflicts.
DR. OVERHAGE: Mark Overhage, Regenstrief Institute, no conflicts.
MS. DOO: Lorraine Doo, CMS, lead staff to the Standards Subcommittee.
MS. WILLIAMSON: Michelle Williamson, CDC NCHS, staff to the Subcommittee.
DR. SORACE: Jim Sorace, ASPE staff, no conflict.
DR. TRUDEL: Karen Trudel, CMS, staff to Subcommittee.
DR. FERRER: Jorge Ferrer, staff to the committee.
DR. WARREN: Okay and do we need to go around for who is sitting in?
MR. ZORRO: Tom Zorro for StataBank.
MR. QUINN: Matt Quinn, AHRQ.
MR. HIROMOTO: I’m Jack Hiromoto from Pharma Solutions.
MR. RODE: Dan Rode, HIMA.
MS. LENHART: Cynthia Lenhart, internal at HIMA.
DR. WARREN: And while you are walking around, Jeff why don’t you introduce yourself.
MR. BLAIR: Jeff Blair, LCF Research in New Mexico.
MR. VALDEZ: I am Guillermo Valdez. I am on a summer fellowship from NCHS.
MS. GARR: Karrey Garr, CMF.
DR. WARREN: Walter and I spent extensive time putting our agenda together. It was one of those funny things. We were asked for an agenda and so I threw out my list and then Walter threw out his at almost the same time and they were identical so something that is going on with the new.
DR. SUAREZ: Interoperability.
DR. WARREN: Yes, this could be scary so we will depend on you guys to keep us in line although I can say that the former Co-Chair that I learned under was always doing stuff like that to me which opens it up. If anybody wants to take pot shots at Jeff while he is here, feel free during the meeting.
What Walter and I have done is we have been working along with Lorraine Doo on these slides for a couple of months. The slides have kind of grown over time because they started out meeting a different purpose so then have evolved into our 60th Anniversary slides so what we would like to do is go over them with the Subcommittee to see if we have forgotten anything or if there are any changes that people would think would enhance the presentation for tomorrow.
The way we are going to do this is I am going to take the first part of the slides telling where the committee has come from in the last ten years and then Walter will take the slides about our new future and where it was. So with that we will go to the second slide, Michelle.
One of the things I thought was critical was that we congratulate all of the Co-Chairs of the committee since 2000. I was really surprised that Jeff was the first Co-Chair of the committee and up until what March of this year, Jeff, he was still a Co-Chair and so everybody else has served with the exception of Walter, as a Co-Chair with Jeff which shows you his impact. So back to Harry’s thing, I want to be like Jeff.
MR. REYNOLDS: I am thinking more and more tainted might be more of a word if you serve with Jeff.
DR. WARREN: Oh, tainted?
Accomplishments during this decade: so Jeff kicked us off on this one since he had lived the decade being Co-Chair and so I was actually very surprised on how much this Subcommittee had achieved during the ten years. Just at a very high level, Congress passed HIPAA and it is spelled right in this one for administrative specifications in August of 1996 and so with that you are going to see a lot of our accomplishments are pretty closely tied to HIPAA. Within the legislation, NCVHS became responsible for selecting and recommending HIPAA standards for electronic transactions, code sets, health identifiers and data security. That was about as trimmed down as Jeff and I could edit it. It is a little long for a bullet but we couldn’t figure out how to do it how to do it any other way. So if anybody has any recommendations for that we would appreciate it.
We also accepted new committee members designated by the Senate and the House of Representatives and that has been Jeff who has been our designee. Then during this time NCVHS created this Subcommittee and initially we were the Standards and Security Subcommittee. We evolved out of that last year.
Any changes that people would like to see for clarity?
DR. OVERHAGE: I guess a detail thing but you say this decade since 1996, which is fifteen years ago.
DR. WARREN: Well the presentation though is 2000 to 2010, oh, you mean in the ah-hah.
DR. OVERHAGE: Well, it lives on. I guess the thought that might be just remove the dates and say this is on-going work. You can say it started in 1996 or something if you want, but.
DR. SUAREZ: Maybe say Congress has HIPAA or HIPAA provisions and stop there.
DR. WARREN: Great, thank you.
DR. OVERHAGE: I just wanted you to know I was paying attention.
DR. WARREN: Those are the kinds of comments we need, Marc. Walter and I have looked at these enough now that I don’t see what is there anymore. I see what I think is there.
So the next one was NCVHS recommended and the Secretary adopted the HIPAA standards for administrative, financial and billing transactions and statistical use and then we listed those: the transaction standards being the X-12, the 4010, NCPDP telecommunications standards, and I think we don’t have 5010 in there. We should probably edit that.
DR. SUAREZ: That is the first round so we don’t have it.
MR. BLAIR: It is included later in the presentation.
DR. WARREN: Right and then for code sets for billing and health claims, ICD-9, CPT, HIP Fix and NDC and then for the unique health identifiers for providers and employers and then information security standards that were out there. Anything on that major bullet?
DR. TRUDEL: Yes, we adopted NDC and then I think we un-adopted it because there were, I think some people were using HIP Fix for some of the transactions.
MS. DOO: In the corrected one.
DR. SUAREZ: Sorry, couldn’t hear.
DR. WARREN: Okay, so take NDC out?
MS. DOO: In one of the modifications rules I think that NDC was removed.
MR. BLAIR: Yes, but in the original announcements wasn’t NDC part of that?
MS. DOO: Yes, it was. I mean mainly more general counsel.
DR. WARREN: So we will get the final word from him. So Karen is tapping into her magic interface over here to get the answer for us on whether or not to leave in NDC or take it out.
Second bullet, NCVHS began to monitor industry readiness to adopt the HIPAA standards, held periodic industry hearings to assess progress, identify and address implementation issues. So we did a lot of those in the last ten years.
MS. DOO: The question was whether the word should be industry readiness to adopt versus readiness to implement since you had already adopted, already recommended to the Secretary that they adopt.
DR. WARREN: Okay, got that one. Anything else? Okay, next slice.
So then Jeff really made the recommendation that at this point we deviate just a little bit from the outline that Marjorie gave us because we needed to speak to building on the Health IT Standards foundation which has been a lot of the work we have had. That is where these next set of slides come from.
Standards for health care billing and reimbursement and statistical use, bullet one healthcare providers and payers have implemented the initial versions of the HIPAA administration transactions, code sets, identifiers and privacy and security standards. NCVHS has recommended and HHS has adopted regulations that the healthcare industry implement the next major versions of the HIPAA standards so migration to version 5010 by January 2012 and to ICD10 by October 2013.
MR. TRUDEL: Would you want to add to the D dot zero for the retail pharmacy?
DR. WARREN: Yes, thank you. I always forget about D.0. I know, yet we have had it in our letters and okay.
The next one on this foundation is standards for clinical use and patient care decisions, support and quality measures. The first one is NCVHS set forth a strategic framework and criteria for analyzing and selecting patient medical record information standards and the Secretary endorsed this framework in 2000. The first set of standards based on this strategic framework, were the message format standards HL7, NCPDP, Di-com and IEEE. Those were recommended in February of 2002.
DR. OVERHAGE: Do you need to say which EEE?
DR. SUAREZ: At ’73.
DR. OVERHAGE: They have got a whole suite of things so that maybe that is too many.
DR. WARREN: So tell me how to say that?
DR. OVERHAGE: I was suggesting that IEEE 1073 as opposed to just IEEE. It just seems IEEE is an organization not a message that.
DR. WARREN: Okay, so replace that with 1073?
DR. OVERHAGE: IEEE 1073.
DR. WARREN: Oh, together. Got it. That is why I needed help.
Okay, the second set of standards based on this strategic framework were identified, or identification of a chore set of clinically specific terminologies: SNOMED, LOINC and RxNorm which were set forth in November of 2003.
The next one is still looking at these standards for clinical use. The first bullet, the message format and terminology standards have been adopted for use by federal healthcare agencies via the Consolidated Health Informatics initiative. Any comments about that one?
MS. TRUDEL: I am being totally picky but we didn’t call it CHII. We just called it CHI and the initiative was lower case.
DR. WARREN: That will be good in case.
MR. BLAIR: Could you repeat what you said? We have always had difficulty with that. So it was Consolidated Health Informatics, CHI initiative, thank you.
DR. WARREN: The second bullet, the chore set of clinically specific terminologies, parens SNOMED, LOINC and RxNorm have now been included in the interim final rule for standards, implementation, specifications and certification criteria and the proposed rule for meaningful use and Health IT to support care coordination, public health reporting and quality reporting. And that is still out for a while.
MS. TRUDEL: Actually the standards are not mentioned in the meaningful use rule. There aren’t any standards mentioned in the meaningful use rule.
DR. WARREN: I thought ICD10 was being mentioned.
MR. BLAIR: Oh you know Karen, I think you are right. IT a lot and the HIT policy committee was mentioning them for stage two and stage three so I inferred, because I wanted to, that it was in there and apparently it is wrong. Do we need to remove that?
MS. TRUDEL: The standards are in the standards rule and the meaningful use criteria are in the meaningful use rule and we have cross-referenced but we don’t repeat.
DR. WARREN: Okay so we should strike out proposed rule for meaningful use in Health IT.
MR. BLAIR: So what is the right?
DR. SUAREZ: Or maybe say and cross-referenced in the proposed rule or meaningful use.
MS. TRUDEL: Right I mean to answer the final rules support the meaningful use.
DR. WARREN: Okay so you want cross-reference to the proposed rule.
DR. SORACE: I don’t have copies in front of me but I really do think they are not even mentioned in the meaningful use rule except to point to that rule as in its entirety for standards.
DR. SUAREZ: To achieve meaningful use we must use the standards so it is highlighting the value of the meaningful use of the standard that we are naming in the standards on certification final rule. That is the value that it has in this slide. It is not just setting the standards. It is then cross-referenced in the proposed meaningful use rule, right?
DR. SORACE: So the meaningful use rule basically says what the standards are.
DR. WARREN: Right, so that is why I say cross-reference. The discussion that Jeff and I had early on and then Walter and I had is that we wanted to claim some of the work that we have done because we spent so much time on it and to show how we fit in with the two HIT.
Okay, next slide then. So we are still looking at our foundations. We mentioned the standards for ePrescribing and so in 2003 the federal government passed the Medicare Prescription Drug Improvement and Modernization Act, MMA which designated NCVHS as the entity to select and recommend standards for ePrescribing. In response to the directives for MMA, NCVHS selected and recommended ePrescribing standards, the NCPDP script and the ASCNX12N, that is a mouthful in 2004 and five which were readily adopted by HHS.
Then HHS funded a series of e-Prescribing pilot tests which successfully validated these standards during 2007 and 2008. ONC now has specified these same standards for demonstration of meaningful use of e-Prescribing. Any changes? Yes, Harry.
MR. REYNOLDS: Do we want to mention that the DEA, that further movement in that controlled substance? I think that if there is something we can say there again that continues to show the journey and we started the first discussions on that and now it has turned into the next because that is really the closer of this whole game going on.
DR. WARREN: Okay and that was this year, 2010, right?
MR. BLAIR: I think the NCVHS role in that directly although it went through a period of years was that we recommended that the FDA come up with a construct so that controlled substances could be included in e-Prescribing and it has taken about four or five years but they have now done so.
DR. WARREN: Then just to clarify, I thought it was only the MPRM that has been posted.
DR. SUAREZ: No, no. The DA published the final rule.
MR. REYNOLDS: Even if they didn’t the point, I think our ability tomorrow is to show that this game just continues and things happen even if they are not to the final note. You can claim, I think we can claim stuff that is in process if we have had a major thing on it even if the final vote is not in, is what I was saying.
DR. SUAREZ: Something like well this could be added to and DA has also adopted the standard for ePrescribing of controlled substances.
MS. TRUDEL: I think what the, if I am remembering correctly, the recommendation was that HHS and the DEA should collaborate on expanding electronic prescribing to controlled substances which we did do and the final end product was the recent rule.
DR. WARREN: I can write that here. So I appreciate that, Karen because I think that is sensitive enough. We don’t want to.
MR. REYNOLDS: I don’t think we should overstate but it shows a continuous want.
DR. WARREN: Okay the next slide, so standards for clinical documents. In 2005 NCVHS recommended HL7 clinical document architecture for use in claims attachment. Second bullet, ONC adopted and in the IFR on standards and certification criteria the recommendation from the HIT standards committee to adopt both the continuity of care document and the continuity of care record for documenting and exchanging patient summary data. Any edits or on that one?
DR. OVERHAGE: Even though I am on the standards committee, I wonder if you just delete that phrase about the standards committee just because it wordier and.
DR. WARREN: We were just trying to share the.
DR. OVERHAGE: Right, that is so I prefaced it.
DR. WARREN: Okay so I mean this is the Subcommittee’s report. Do you want to take Marc’s recommendation that we eliminate HIT standards committee?
MR. BLAIR: Marc, just to make sure we are thinking about the same thing, this is the new HIT standards committee that was not part of NCVHS, that is part of ARRA.
DR. OVERHAGE: Right.
MR. BLAIR: Are we thinking about the same thing?
DR. OVERHAGE: Yes. I am a member of that committee so I am sensitive to it.
DR. WARREN: That is why I was deferring to Marc on that one because I didn’t want to step on any toes earlier.
DR. OVERHAGE: I don’t feel strongly. It was just like this was a mouthful and it was a piece that really didn’t add a lot for most people but I understand where you are going.
DR. WARREN: So maybe when we just go through it we not mention it.
MR. BLAIR: Shall we refer to it as an unnamed committee.
DR. OVERHAGE: No.
DR. SORACE: Judy is it your intention that those two bullet points are linked and that the second one follows up from the first and that they both mention the CCD because a lot of people with they are lay don’t understand that CCD is a CDA and they might not quite understand that, that is basically what you are saying. I think what you intend to say is that the continuity of care document standard is actually a CDA related standard.
DR. WARREN: Well Jeff and I both looked at that and what we recommended was CDA.
MR. BLAIR: We recommended CDA because at that time there was no CCD and the CDA, when you combine the CDA with the CCR in terms of content, essentially the CCD is now a combination of the CDA and the CCR I mean in general terms.
DR. WARREN: We could do that. We could say has adopted the CCD which is based on CDA standard and not say anything at all about the CCR.
MR. REYNOLDS: The only reason that I use those words was that I believe that those are the words in the IFR of 2011 is they include both and I think I used the words right out of the IFR. Other than my stating that so you know where I got it from, change it at your will.
DR. WARREN: I have modified it to read HIT Standards Committee adopted the continuity of care document which is based on the CDA standard for documenting and exchanging patient summary data. That why it shows the link that you are talking about. I would hope our audience would understand that. We don’t know where all of this stuff is going to go eventually so it would be nice to have that link. Good points.
These are the challenges for the next decade that Walter and I came up with. So you flipped over from Jeff and I doing the first set of slides, the next set which he has to present by the way. So with that, why don’t you take the mike and go through and I will keep track of your edits for you.
DR. SUAREZ: Should we listen closer or less?
DR. WARREN: I just work with the guys, you know.
MR. REYNOLDS: You just bring along the ones that have been here a long time and the ones that are new at their job. I like that system.
DR. SUAREZ: So we started with the challenges with extensive work that we are going to have to do around the healthy reform legislation so we have this as identify and recommend standards associated with the new administration specification provisions in the E-Pack at 2010. I understand the administration does not like this to be called E-Pack at 2010 but more.
MS. TRUDEL: We call it ACA, Affordable Care Act.
DR. SUAREZ: Oh, Accountable Care Act? Affordable Care Act.
DR. WARREN: Let’s modify that to Affordable Care Act or ACS?
DR. SUAREZ: ACA, so that is a significant challenge to lead in the next decade as it will take about a decade to implement all of this.
The second bullet reads, ensure that health IT standards are developed within the context of an NT model, public health policy in the data store ship framework and the needs of the users. This is another important challenge for our Subcommittee and it combines basically these various aspects that are evolving in public health policy data store ship and certainly the needs of the users.
The third bullet accelerates adoption of clinically specific standards and the extension of HIPAA standards in the Recovery Act of 2009.
MS. TRUDEL: Walter, could you say more about that?
DR. SUAREZ: This is adoption of clinical specific standards so this is basically the standards from the HITEC that deal with clinical areas in terms of data. Clinical data is entered and the extension when we think of extension of HIPAA standards in the Recovery Act.
DR. DOO: I’m not familiar with those. I wonder if is not led to the privacy or security.
DR. WARREN: I am trying to remember now how we evolved this statement but HIPAA does start talking a little about the quality metrics that are there and if you look at those, those really are extensions of clinically specific standards. Now does it say extension of HIPAA standards in ARRA? I am not sure that that is a precise statement but it certainly shows that we are building on HIPAA and pushing that work through hard to achieve those. Now is that going to cause difficulty in understanding? Do we need to rephrase that?
DR. SUAREZ: Maybe moving in the ARRA 2009 just before the and the extension of HIPAA standards.
DR. WARREN: Okay.
DR. SORACE: Do you want to mention anything about ICD10 specifically.
DR. WARREN: We have already. It was in there earlier.
DR. SORACE: In the next decade, we said that it was going to be implemented this decade but that creates opportunities for more data finding.
DR. WARREN: That is on our next slide because we do say work with industry towards a successful adoption of the next version of HIPAA standards and code sets which is 5010, D.0 and ICD10. We should probably change that to implementation now.
DR. SUAREZ: The next bullet would be, recommend tools and methods to make implementation of standards easier. Here again it is really the concept of going beyond just selecting standards but now beginning to look at tools and methods. That is also part of the Health IT Standards Committee is looking at with respect to the implementation of the health information of fee standards and the health IT standards is now looking at tools and methods that help the industry implement the standards.
DR. WARREN: So an example of this would be NIST just recently developed a test bed for some of the standards we had recommended early on.
DR. SUAREZ: Then the next bullet is identify health IT standard gaps and create solutions. Certainly we will mention here that I think it is going to helpful and important to mention that we will continue to work in coordination with the Health IT Standards Committee just to make sure that people do not perceive some sort of level of duplication of efforts for meeting our challenges as we see it.
Here we start this slide with a bullet about the adoption and implementation really of the successful implementation and maybe we should change the word. So work with the industry towards a successful implementation of the next version of HIPAA standards and code sets.
Next bullet is advance integration of clinical and administrative standards, avoiding fragmentation and duplication in both internal business processes and external interoperability. Here the concept being as we move more and more towards maturing administrative transaction standards and incorporating and adopting and implementing clinical standards, there is more and more a growing need to integrate those two so that we don’t have systems talking administrative and systems talking clinical but a common system talking both basically and everything else. So that is a concept around a future challenge that we see in the next decade.
The next one is meet new health and healthcare requirements such as medical homes, personalized medicine and clinical research, health surveys, and syndromic surveillance, human genomics and other omics and others. So it really is beginning to incorporate all of these new approaches and perspectives on how to deliver and improve health care; each of the work of the health data standards of our committee.
Then I would like to talk about the Health IT Standards increasingly moving internationally in development and use required requiring new models of collaboration. So here we actually try to give them certainly the importance of the perspective of the international role of standards development and use and that we are not really isolated in our industry in this country. We are much more globally in that sense.
DR. CARR: You are doing twelve slides. I thought we were limited to six slides just running ahead for quality consent.
DR. WARREN: We have fifteen minutes and we will be done in fifteen minutes
DR. CARR: Oh, I see.
DR. WARREN: Each side of the committee has fifteen. The problem we had was that if we were to put them on six slides, you would never be able to read it. So yes, we took a little bit of license and we will be done in fifteen minutes. I promise.
MR. REYNOLDS: They are counting on the switch over of chair. They are kind slipping it in between. I am not sure who has the power right now so you have to watch.
DR. CARR: Yours is a great, in depth. I think we can back and write up.
DR. SUAREZ: And being in the middle of the population subcommittee and having to work on those slides as well, we are sort of in the same number of slides with them, too and twelve slides so we are going really slow here of course to possibly help you incorporate the changes.
The next slide is the last slide on the challenges so we wanted to step back and say a few words about Health IT Standards really and bring all of this to closure within the perspective of the ultimate goals of Health IT Standards so the first bullet you know tools need to be developed and managed, burgeoning and harmonization of standards and then the ultimate goal of Health IT Standards is really to number one, support the information exchange needs of a healthcare system; empower consumers to improve their health; and ensure high quality healthcare delivered efficiently and securely and effectively.
So within that set of goals within the Health IT Standards, we think that some of the chore things that we will need to do as we move forward to address these challenges is going to be maintain and always reference back to the basic principles of health IT standards and we list them here. The first one is standards to be developed with user input; diversity among participants should always be encouraged and sought after. Standards should be developed in an open consensus base manner consistent with ANSI guidelines. Standards should be developed with a facilitative interoperability and better decision making.
MR. REYNOLDS: Question on that and again I will show my ignorance but it won’t be the first time or the last one on this committee. Are all standards going forward going to be based on ANSI?
DR. SUAREZ: Not ANSI but based on the concept that ANSI provides that the process should be open and consensus driven. So it not the standards are not ANSI standards. The process of open and consensus base is a guideline.
MR. REYNOLDS: Again, so guidelines is a key word. You may want to even underline it or something.
DR. SUAREZ: That is a good point, yes. It goes back to, I now and then go back to reading some of the original rules, the HIPAA rules and the criteria imbedded in the standard organizations that were to be looked upon include this open consensus based standards. So yes, I think it is going to be important to mention this as a guideline.
MR. BLAIR: Specifically Harry, back when we were originally identifying the HIPAA standards, we had a list of twenty characteristics called guiding principles and one of them was that the standard would, the standard organization would be accredited by the ANSI standards organization because of the processes that Walter just mentioned. It did leave us latitude to pick something that didn’t, that wasn’t ANSI accredited but at least had the attributes of the consensus base process for developing standards.
DR. SUAREZ: Thanks, Jeff. And so they are thankful that we have a standard. This is where our technology, architecture and process requirements are. And I think with that that is our last slide.
MR. REYNOLDS: A question on process, go back to that last slide. Standards should not specify a technology, architecture or process requirement. Will that hold in the future?
DR. SUAREZ: At least the first two will continue to hold: technology and architecture. Process in the sense of now in light of this new operating rules development there might be some you know area where the operating rules are going to, you need to define some of the process.
MR. REYNOLDS: Again, not challenging it but since we are kind of talking about where it is going and how we want to align to it in the discussion. I am not asking you to change anything.
DR. WARREN: I think the discussion is because I see Marc shake his head and then look perplexed. My personal belief is that we don’t want standards to specify exactly how to do things. However, we do want them to say you can do whatever you want as long as they meet these criteria. That allows us then to improve processes and not have them specified. It also allows us to continue to explore new technology, etcetera, without given specific directions where technology needs to go in the future. Now will that hold up for very long? I have no idea. The rate of change right now is huge that I see.
MR. REYNOLDS: What I think is just as important right now since everything is moving so fast. This committee, if it looks at the maturity of the rhetoric, because remember this stuff is evolving and so the question was about the maturity of rhetoric still today not questioning what has gone on and I am not questioning the future. Is this the level of rhetoric that is needed for all of the changes going on and I have zero perceived, perception as to whether it is right or wrong. That is the one thing that the committee will need to continue to do because the old words, we need to recalibrate. But the old words work in the new environment and work in the next new environment. That is really going to be important because this industry is really moving and shaking.
DR. WARREN: So some of the things that both Jack and Walter and I talked about in doing these slides is one, it provides us with a benchmark to go forward with. This is our thinking as of the 60th Anniversary of where we think this Subcommittee is poised, what we are building, the work we have done. So it at least gives us a touchstone as we go forward we have some basic principles that we can look back on. Do we still believe these? Are they still in play? Do we need to redesign these and use them to look at future work?
MR. REYNOLDS: The reason that I say that is as I go around out there, there are so many new entities entering the health space. You are coming from different standards mindsets, coming from different philosophies, coming from different approaches. If you ever use the term retail healthcare, I mean it is a real term out there and so again, let’s just make sure that the committee continues to watch the ecosystem neither up here to be protecting the current way but just revalidating each time.
MR. BLAIR: Can I suggest something that I think might accommodate Harry’s request that these be not too constraining or demanding? I am not exactly sure what is on the page but if the page says basic principles, if we said guiding principles instead of basic then that gives us more flexibility to recognize exceptions to these if they have other attributes.
MR. REYNOLDS: Yes, I think guiding principles because you may continue to change the basic principles but the guiding principles are always going to be there.
MR. BLAIR: Then I can totally agree with process requirements because you don’t want it to be doing things that it shouldn’t be doing.
DR. SORACE: Would you like to say something like standards should not constrain innovation?
DR. FERRER: I think it is a difficult balance to strike as we do want the standards sort of at the data model because if we don’t do that then we are not the power of the component of the data that is within a system. By the same token you don’t want the standard to constrain innovative changes in technology. I think that is a strike. I don’t know how to say that but I think that is the sentiment I have heard.
DR. WARREN: That was some of the things that we talked about. We thought that technology architecture and process were a cleaner way of talking about it. I always get concerned when we say we are going to standardize the data model because the model has so many different meanings.
DR. FERRER: Right and even the context, as an example, the content. So if you want to bring the HL7 model, you know your standardize the structure by which that exchange occurs, right? So we are not all trying to broker or build that thousand interfaces so that is just an example. I think it would be ridiculous to try to normalize all the clinical data and put content is would be the next hundred years doing that.
DR. WARREN: So that gets back to semantics again. The HL7 has an information model which is fairly conformable. Having been part, at one point in my life of working on the rim, I can’t imagine having to say some sentence about healthcare that I can’t model at the rim you know at some level or other. But it doesn’t dictate my data models. Again, we are in this moving system of how we are using words to describe what we are talking about and different people have labels. So it is always nice to define what you mean by data model. With me I am pretty down in the weeds with the data model so it is my data base design.
So we are going to change and instead of maintain basic we are going to put guiding.
DR. FERRER: Judy just let me clarify that. Based on what we just said from an information model concept the code sets of themselves are pretty restrictive, right? There is no ambiguity in what that means and that is a requirement from a billing standpoint, so it is not like we are really change a whole lot of that. I think what the problem that we are running into is that expressivity of confidence comes in at the front end. How much of that do you want to constrain? Probably not a lot but at the same, at what point does that information become so structured that actually you can search against it. I mean I don’t know the answer to that.
DR. WARREN: Yes, I think that is going to be up for grabs for a while. Did we address our concern?
DR. SORACE: No, it is fine. I am just tossing out the fact that if you once address life constraining innovation for the general audience, it might be a value but yes, there are many things you can say and there is little time, so.
DR. SUAREZ: That is so but the way I see it is it sort of a hunt and wait for the last bullet really or a natural expected consequence. That is the standards are not going to specify or not specify technology on a particular process, not going to constrain innovations but on the contrary foster innovation within the context of that innovation being able to use those standards. Even that could be said as I would actually save that bullet.
DR. WARREN: Okay so what I am hearing from people, the edits that we all agreed on I will make sure that they get into the slides before they show up tomorrow afternoon but I would like for people to remember, especially you, Jim, on your comments is where we get into future planning. That may be more when you want to bring out more and you will have the time to address it and make sure that it is there.
For me it is this page really does move us forward to where we need to go next as a Subcommittee. The others are challenges that we need to address along the way but these are kind of some marching orders.
Okay any more questions about the slide or what we are doing tomorrow afternoon? Okay, then we are going to jump in on a fun stuff that Lorraine and Walter and I have been working on for the last couple of months. Has it been that long?
If you have not had a chance to read the ACA in all of its glory, we are mentioned I think Walter what five times?
MR. REYNOLDS: At least, yes.
DR. WARREN: About requirements the NCVHS has in the Reform Bill and so Walter did a wonderful job and I think that you have a handout in your basic, in what you were given this morning on a table that Walter put together on what the because all three fact committees were mentioned in the bill. Walter did a really nice call out for what each one was responsible for so as you start thinking about our work, it looks like this is a bunch or words: summary to key health information and informatics and information technology domains and relationship of fact committees with Walter Suarez as the author. So that is just informational.
Now what Walter and Lorraine and I did was then go through that bill and we are in the process of putting together educational requirements for the Subcommittee, or educational documents for the Subcommittee so that before the hearings you will have a chance to read up so that you may come in somewhat knowledgeable. I think we are going to learn a lot during the hearings.
So we, within a year’s time we were given very specific dates of when to have certain things done. So Lorraine and I sat down with those timelines and went backwards to see when NCVHS had to do their stuff. We have to have a letter to the Secretary approved in September so Justine heads up for September agenda, on recommending the approach to health plan identifiers.
DR. DOO: That is both of them in that timeline? I thought we had until November to do.
DR. WARREN: I am sorry. I won’t say that.
DR. DOO: Makes me breathless.
DR. WARREN: So with that I am going to turn it over to Lorraine and have her walk you through the agenda and some of questions that we have come up with to ask these people to talk to. So as you have questions you can add them here.
MR. REYNOLDS: Before it starts, what is the process? If the committee is, which it is being asked to do a lot more, has that been aligned especially from this Subcommittee with Marjorie for budget to ensure that it happens?
DR. WARREN: Right, the other good news is that we have Margaret A. to help us.
MR. REYNOLDS: The other thing is as these things are going to happen faster there may be more controversy around them and more discussion and so even though there is going to be a hearing, there may be follow-up calls for making sure that those calls are visible to the industry and everything else will be key because you will probably going to have to make more decisions than we have ever had to make as a Subcommittee and full committee over the phone and figuring out knowing how to work that with other people that may want to say things is going to be again I am just stepping back looking at what is the change in the landscape right now.
DR. WARREN: One of the first things that Lorraine and I came up with because we were still in transition and I am not sure that Walter was made co-chair yet, but I kept seeing dollars and funding of the hearings and so Lorraine and I talked. We made sure that we got Marjorie on board for budget and also Bill and I think CMS was involved. Was it something that CMS involved with that?
DR. DOO: For getting Margaret A.? Actually through ASPI.
DR. WARREN: ASPI, okay. So we tried to hit all of our buttons getting budget for the hearings, the right people. We knew that we were going to be moving fast so we wanted to have a consultant work with us to help write everything and so I think we are good. Plus the committee has experience with Margaret A. and we have done good work her before.
Anything else, Harry just in case we might have forgotten a step?
MR. REYNOLDS: Well and then how would you guys explain to the full committee. Does the money needed for this Subcommittee restrict any other movements for the rest of the Subcommittees in the committee as to what they can and cannot do?
DR. WARREN: I don’t know that. We also don’t know whether or not this is our only meeting.
MR. REYNOLDS: Justin has got that. She has hit me three times already so this is just.
DR. WARREN: I think those are all interesting challenges. It is one of the things that Walter and I have talked as we have looked at where the Subcommittee needs to go next is does this count for our work this year or can there be other ones. So we are still in there negotiating. We have not heard anything final.
MS. TRUDEL: I think that the critical situation here is getting us through this fiscal year because nobody anticipated that we were going to have this workload so we now know and we have the ability to plan when Marjorie and her staff puts together the operating plan for fiscal 2011 and was a better idea in advance of what is needed.
DR. DOO: Can I talk a little bit about he agenda?
DR. WARREN: Yes.
DR. DOO: All joking aside on the recommendations that we will need from NCVHS in the first two things that we have to do is our regulation and establishing a health plan identifier and adopting operating rules for eligibility and claim status. There is a date certain for publication for the regulation for the operating rules which is by July of 2011. There is not a publication date for the health plan identifier but the compliance date for the industry is October of 2012. So again working backwards one can easily see that if we give the industry enough time to develop a systems that they will need, processes that they will need, what we will need to do to build systems working backwards, we are back into 2011.
MR. REYNOLDS: So I am jumping again fast. I moved further away from her. The committee had set up and recommended as a part of ICD-10 and other things a two year glide path of regulations. So now there is going to be one that is due ’11, one that is due ’12 and one that is due ’13. Is that what I heard?
DR. WARREN: The regulations will be published in 2011.
MR. REYNOLDS: You said the compliance date was 2012.
DR. WARREN: That is correct by legislation.
MR. REYNOLDS: No, I understand what but again so that the committee as it explains itself because a lot of people have used that as kind of the stinger. You may want to get out in front of that early and say that because the legislation was passed that way, this is not because people are going to be coming back here and saying wait a minute you set up a glide path and now you are going away from it and it is just again.
DR. DOO: So let me pass your advice.
MR. REYNOLDS: All of this stuff we are going to have go back and look at what we did and then how it got changed and what we did here.
DR. WARREN: So my intent is we preface each morning of the hearings with an opportunity to give an overview and so Walter and I will be sharing that, was to have a slide that says you know legislation requires by so what our ground rules are. Now I didn’t think about it in terms of the glade path that we recommended. Should that also go on that slide?
MR. REYNOLDS: Well I am not sure it should go on the slide. I am just saying it is something that will be an elephant in the room because as a full committee we felt that people shouldn’t be changing their systems and working on the next one at the same time and now we have 5010. They are at the ICD10 right within a basically within a twenty-four month period of implementation.
DR. SUAREZ: In reality this January first of 5010 and the first of 2012 and then October first of 2012 is this Plan ID and I have actually a time line here and then January first of 2013 is the operating rules of elect-ability and claim status and then October first of 2013 is the ICD-10.
MR. REYNOLDS: The implementation dates are the issue far more than the final rule date.
DR. WARREN: Especially when you take a look at Chuck’s slides today about how many people we have that are educated to do this. And we don’t have enough as things are today much less with these other timelines.
DR. SUAREZ: Lorraine perhaps the other important part point to clarify to the committee, the Subcommittee might be that terms effective and adopted as well as compliance and, etcetera.
DR. DOO: And in the briefing papers we absolutely will because there are charms used in legislation that have not been our up to this date what we have been accustomed to hearing.
So let me just walk you through briefly the strategy for getting the committee ready for the hearings that we are going to be having in July and then talk about the actual hearing. On June 23rd, we are actually having a small stakeholder meeting to gather some information from the industry specifically on health plan identifier so that we know a little bit more about what people are thinking so we can put that in a paper that will be provided to this Subcommittee at a meeting we are having on June 28th.
MR. REYNOLDS: Is that CMS going there?
DR. DOO: Yes, CMS is doing it. It is a phone call and it is to help us get grounded in what is actually out there that we can make sure to the extent possible we are not missing anything up front in the advance materials. There will be a briefing paper on both the health plan ID and on these operating rules for eligibility and claim status.
Then the hearings are July 19th through 21st. We will soon have a location confirmed. I think it is all but confirmed except for the contract being signed. So we won’t say anything yet until we know for certain but the first day and a half will be dedicated to the health plan identifier and we will start off with a general introduction of what the legislation requires. It is fairly simplistic and then what the history has been up to now of what happened with identifiers and then some experience from industry as well as from CMS and Medicare on implementation of a provider identifier. So that there are some lessons learned from a variety of people.
MR. REYNOLDS: Can you add to that what, anything about the original wording, the original discussion as to what it was put out to be?
DR. DOO: For the plan identifiers specifically? Sure.
DR. WARREN: You mean from HIPAA or from this? That is kind of what Karen will do.
MR. REYNOLDS: Okay, good.
DR. DOO: Just to get everyone grounded like here is where we were; here is where we are now; here is some lessons learned and then we will have panels representing different segments of the industry and the covered entity industries so there will be providers, health plans and when we say providers we talked about this earlier, we don’t just mean doctors or hospitals. There will be a gamut. Same with health plan community and then clearinghouses and vendors and other entities that will come forward to talk about the health plan identifier.
Then there will be some time for the committee to talk a little bit and get some grounding before we move on to the next day and a half which is a turnabout because we will be talking about operating rules which are designed to support the standards. That’s helping the standards do what standards are supposed to do.
Similarly we will talk about the history of standards: what we have; what we don’t have. Then move into we are calling them candidates and I don’t know that we will keep that words but essentially entities that have come forward saying I have an idea for what could be an operating rule. There is no definition in the legislation of an operating rule other than an operating rule, and I don’t have it with me but it is very simplistic about an operating room supporting the use of standards. But what the legislation does have are some criteria for the authoring organization and for the operating rules themselves which we are transforming into a checklist if you will, some guidance or guidelines that you all will be able to use as you are hearing what people are saying about these operating rules and what they can do and how they are created. So it will help think through and that will be part of what we are give in advance so that people can come up with some other suggestions as well.
Then we will have input again from the industry segments about what operating rules mean, what their expectations are, what the gaps are and what they hope that these will serve. So again from each industry sector and then from vendors, clearinghouses, code content committee and a couple of other organizations that have offered to step forward to talk about the utilization. So it is pretty diverse testimony that you are going to be hearing on those three days.
DR. CARR: The specific thing that we are being asked to advise on is advise the Secretary as to whether the nonprofit entity meets the specific requirements. So the hearing will be about entities or about requirements?
DR. DOO: It will be about the entities offering these rules that made these requirements.
DR. CARR: And so it will be an assessment of the entities’ ability to meet those requirements?
MS. TRUDEL: So it will be first an assessment of any operating rules to come forward. Are they appropriate? What do they do? Do they meet the intent of the law? Then the second step is differences in the operating rules put forward with fine organizations. Does that organization meet the criteria? Both of those things have to be true if you want to make a recommendation to the Secretary to say adopt.
DR. CARR: Again I am being simplistic and I apologize so entities will come forward and say here are my operating rules and here is how they meet and then NCVHS will decide among them that one entity is preferable over the others?
DR. DOO: I think it is a fairly open door. You could in fact recommend two or three organizations or for one rule from one organization and one rule from another organization but and that is why we are going to do these checklists of examples because it is a little nebulous in the legislative language. We are trying to come up those things.
DR. CARR: And have a diagram.
DR. WARREN: Karen has got the legislation which to me is.
MS. TRUDEL: Okay, the first thing says advise the Secretary as to whether a nonprofit entity meets the requirements under paragraph two. Then b, review the operating rules developed to recommend advise by such nonprofit entity and then c, determine whether such operating rules represent a consensus in the health, your stakeholders, and are consistent with and do not conflict with other existing standards. So it is kind of as Judy said, open as to whether we are going to say we will select one entity and it will develop all of the operating rules or that we might entertain a variety of operating rule developers each bringing their own so we might have an operating room from NACCHO for electronic funds transfer and another one for CAQH and another one from HL7.
DR. WARREN: To me that is where we have to be very careful how we structure this because we could get into some real difficulty.
DR. CARR: Just one other question. So selecting the people to testify, are we pre-selecting candidates?
DR. DOO: We have had some MD’s come forward to us and clear with standards themselves who want to talk about it. In the federal register notice that will go out announcing the meeting it actually gives other organizations the opportunity to request to be on a panel to present themselves. If there is somebody we don’t know about that has not come forward yet, they will have the opportunity.
DR. CARR: So every organization that wants to present will have the opportunity to present?
DR. WARREN: Well not necessarily because there is a limited amount of time but we will make available written testimony opportunities as well as in person.
DR. SUAREZ: The other important thing and it can perhaps emphasize some of the things that have been saying is there is a priority of identifying two or operating rules: one for eligibility and one for claim status. I believe, right? So that is the primary priority. There could be operating rules authoring entities that are not presenting necessarily perhaps operating rules on those two transactions but they are potentially entities that could develop operating rules in other transactions. So that is why it is important to consider both as Karen was saying. It is really one thing is the operating rule, the authoring organization itself and then the next thing is operating rules themselves and the operating rules for these two transactions. So and as mentioned, there could be a situation where one entity is the most likely entity to be recommended to be offering a particular operating rule for a particular transaction but that doesn’t mean that that is the only entity that will write all of the other operating rules. Ideally I presume we would not have two offering entities offering one single set of operating rules but I mean those are things that we have to be open to consider. So we want to be certain to point out that we are I think very open to listening and understanding the organization’s perspective, background, experience, how they meet this requirements under the law to be an offering entity and what are the operating rules and the transactions they are proposing the develop operating rules.
DR. CARR: I guess this is my final question so the first two are eligibility and claims and then for claims status transactions and then we have another go-around for electronic funds transfer, healthcare payment and remittance and then another one for health claims or claims attachment, lifetime employment.
DR. WARREN: We are going to try to put all of this into a briefing packet for all of the members of the Subcommittee so we can keep it straight.
DR. CARR: I would ask, if I may that we submit and give it to all the members of NCVHS because as we talked about it, I think that we all need to be engaged in this. We all need to understand.
DR. WARREN: Right and that is why I asked Marjorie if we could invite a representative from each of the Subcommittees to be present at this hearing and she approved that. So we still have to get who that person might be and even though there are several of us, like several of you sit on two committees, that may be the representation that Subcommittee wants or they may want to ask another person to come in and Marjorie and I decided that decision needed to be left up to the co-chairs on how they wanted to staff that.
MR. REYNOLDS: Let me give you a specific example of that. You take eligibility and then you start talking about how far you are going to go with eligibility and there is sequestered data gets into play. If you say that somebody has met part of a deductible in a certain place that starts moving into privacy so that is why I said earlier this is, most of these things, you know eligibility people just think you are covered or not. No, as you talk about operating rules you are talking about how do we really do business and then you are going to get into all kinds of stuff and so as you communicate maybe to these other people in these committees trying to get some like that example right there, Leslie, John, somebody from privacy needs to be there because whatever you say and do is going to set a standard and going to set that is or isn’t and could be challenged then back to that committee or challenged through somebody else to do something with it.
DR. WARREN: And I think that is the challenge to doing the operating rules is because for me when I first started reading it, I thought it was how to fill out the form and it is not. It is much more than that. Okay, Dan, come up to a microphone and we will let you chime in as well.
DR. RODE: Dan Rode, I am with HIMA: two different hats. First, my HIMA hat as one of the groups that sponsors the legislation I will tell you that there were a number of semantic issues that came up during the testimony and working with the committees and that included the difference between implementation rules and operating rules and you kind of gone around that subject.
My old hat on as co-chair of the Health Care Task Force for the X12, when we presented this idea in 1993 we did so as a result of interviewing and talking with a number of industry councils in other industries. In other industries, unlike health care, there has generally been an industry council made up of different organizations who come together and determine the operating rules for that industry. The easiest one to point to used to be auto industry where the Big Three got together, sat down, looked at the X12 transactions, decided which transaction they were going to use, how they were going to use them and then they sent the letter to their suppliers and said this is how you will use this transactions or you don’t do business with us. They had a bit of power to do that.
The problem as we began to look at what became HIPAA was of course there is close to two million entities in healthcare. That creates a problem and what you are now facing and I think the HIT Committee is also facing is you are the industry determiners for these operating rules. The one caution I would have we look at the original transactions which are a lot simpler than what you are talking about right now is the fact that they all interact with each other. So in looking at operating rules you can’t look at just one transaction. You have to be thinking about the entire piece.
So if it is any help to you, I would urge you to work through ANSI or work through one of the other groups and talk to a couple of the other industry councils in other industries: the utility industry; the transportation industry they all have these councils and they have been in operation for at least thirty years. They might be able to give you an idea of some of the things that they have run into that would help you with your criteria.
DR. WARREN: Thank you, that is very helpful.
DR. DOO: Dan, we did speak to NACCHO recently because they have operating rules. Is that another good?
DR. RODE: NACCHO has been a banking committee for, yes, many years.
DR. WARREN: You can just nod your head. You don’t have to come back. Should we look at more than one of these councils? All right so we probably need to pick another one to talk with.
DR. SORACE: I think part of the challenge that we will have is to refining and clarifying the definition of what an operating rule is because there is a wide variety of perspectives and understanding and depending on the transaction it could many different things, too so I think that is going to be one of the most important in the elements in the discussion of the hearing.
DR. DOO: So that is if for the hearings. I don’t know if there are any other questions. One of thing just from a date perspective, Walter you were talking about your timeline, the other thing that you wanted to know about hearings in 2011. Obviously you will be having hearings on the EFT and remittance advice standards and operating rule but also beginning to look at the current standards and making recommendations. That will happen in 2011. So it is a lot of work next year.
DR. WARREN: We are taking it step one what we have to do in 2012. I think quality is becoming a hot topic as well. Everything we are doing is becoming a hot topic. It is getting really hard to figure out where to put the resources.
So we have a phone call scheduled for the Subcommittee on June 28th so as you think about what we have talked about here, the people that are testifying. Have we sent out the questions that we have asked the testifiers to answer to the Subcommittee?
DR. DOO: Not to the Subcommittee. No we will send a copy of what that letter is because it has what each group has been asked to talk about. We will send that out tomorrow. Then the briefing papers, we are expecting our draft on the 21st and our goal is to get it to you by Thursday because the call is the following Monday. I don’t want anyone to be expected to read on the weekend so we will at least give you a day. Then we will be able to reread.
DR. SUAREZ: You have to kind of nice with the Federal Registry notice that they are?
DR. DOO: We have not yet heard back from the Federal Registry notice people. We wrote it. It is there and Marietta said as long as it is fifteen days in advance, which is not our favorite thing but it has been done. It is waiting to go through it. As soon as we get the link we will send it out.
DR. CARR: Is part of that you were mentioning you don’t really have a definition of operating rules.
DR. SUAREZ: The legal definition. We have the law definition only as a reference point.
DR. CARR: Right, but you just said we don’t have.
DR. WARREN: I said that. I think when I read the bill it was not incredibly clear. So I read it first as this is how you fill out the forms was what I thought they were but I think they are much more than that as Dan is nodding his head back and forth and so is Harry so to me a lot of this is educating. I am not sure I understand the full scope of what an operating rule is and the legislation didn’t help educate me very well.
DR. CARR: So is that a deliverable out of the hearings that we will become educated by the perspectives on what actually.
DR. DOO: Actually we hope in the briefing paper it gave you more to chew on. You know based on as we said we talked with one other industry and now on good advice, we will be getting more.
DR. WARREN: That’ right so let me ask you too, should we send out the briefing paper to the whole committee?
DR. CARR: I think so. I mean this is the work of the committee for the next 2016 or something like that so you know.
MR. REYNOLDS: The only thing I would caution in a little bit of deference to Dan is I think selecting the industry where the operating rules are how you do business and the idiosyncrasies of how you do business not just if you are going to do business with me this is what you will do. I am not challenging, not adding or subtracting from what you said. I am putting it out because I think what is extremely important, if you doing an ATM transaction it and it says you will do this and this and this. If you are doing an eligibility where we just talked about you might list 64 different types of coverages and as soon as you put a number in that they have used part of their deductible in psychiatric or in this or that or anything else, you have now moved into a whole different chat about the person, the business and the other things. That is all I caution the team about this. We are in an industry that is coordinated, uncoordinated and personal as it moves along so out of safety as that is being discussed it is extremely important. So if you an find industries that are dealing with the general public and their information and the business around them that I think would be a wonderful opportunity. I didn’t say I had a list of them but I am just saying to you that that is a key other ingredient as you think about this because it is not just the data and the package. It is how you do business.
DR. WARREN: One of the concerns I have and Justine if you have a different one we need to add that too is that as we start talking to the full committee, even the Subcommittee and then the full committee about what we are recommending and what our task is for these operating rules, everyone is going to come up with what is an operating rule. Because there is no real clean definition, do we have any good examples that we could put in there?
DR. CARR: I was just thinking the same thing.
DR. WARREN: Or like a use case or a story or something like that because I think that would really help us put our arms around what it is we are trying to approve or recommend.
MS. TRUDEL: I can’t provide very much context but I did spend a fair amount of time in some of the discussions with committee staff and the two things that I heard the most in terms of what they were desirous of changing were concerns about companion guides; committee companion guides and a lot of people were pointing to the CORE operating rules as a model. Now the CORE operating rules do contain things other than what you put in this field and what you return. It is you know what is your service level agreement in terms of when you return the agreement back? So a couple of models might be what CORE has done and also what Minnesota has done in terms of its single statewide companion guide because they are coming to.
MR. REYNOLDS: Everybody knows I am chair of CORE that is why I am trying in every one of my comments has been completely above any of that. I would not relate it CORE. You asked for an example I would use the example of eligibility. I would not use any rule from anybody and that is why I was saying that earlier. I would eligibility. What came out and what did the operating rules look like and what does it mean; not win or lose. Then you can very clearly see the difference between the two. They are no longer different and then you go meet with everybody and do your decision but I think as soon as we attach organizations of any kind to any of this it starts to swing the pendulum and it starts to put people plus and minus and for and against and I think that is one thing great about NCVHS is we have been able to in all circumstances rise above that and that will be very important to keep very clean in this one so that as things go forward.
MS. TRUDEL: Let me clarify. I was just trying to provide these were the things that the people who were working on the legislation were responding to. Things that they had heard about that they heard were good and would be helpful.
MR. REYNOLDS: Right and I spent a long time as you know with them too. So I am very familiar but again for the hearing, I think a subject like eligibility would be a great one to very clearly put up there.
DR. WARREN: Do we have someone who can put that together for us?
MR. REYNOLDS: The summary examples, you mean?
DR. DOO: Part is of what is going to be in the, I think, if I understand what you all want is when the entities speak, they will be talking specifically to eligibility and claim status and what these gaps are and what problems they solve from what currently exists. Because we are actually having a gap analysis done of what the standard doesn’t do and what the existing operating rules are that we know of that there is several of where it fills that and that is going to be part of the paper that we will give so maybe we can find out if that is sufficient to help people have an understanding of what these rules can help solve.
MR. REYNOLDS: Again, eligibility is very, is the cleanest and easiest.
DR. WARREN: I guess we will just wait to see the paper and then see if it meets.
MS. TRUDEL: I was just thinking if that is the easiest one we have got, we have really challenging work ahead of us.
DR. SUAREZ: Well I am not sure it is necessary.
MR. REYNOLDS: It is only because it has had the most work done on it. Let me say it that way. People are more astute at what the end game is or is not.
DR. SUAREZ: Clearly one of the issues is the clarification and I mentioned it already but it is the clarification of the definition of operating rules. So this example will help.
I think from my view I think it will be very helpful and OCR has that list constantly with respect to regulations and privacy of course. At the end it will be helpful to have at some point guidance being issued on the definition of operating rules and the FAQ on what operating rules are and what they are not because in many cases people might be extend the definition to broad issues that become.
If one of our charge to come up with recommendations and I think to make it into the and then this is maybe already getting into some of what we would recommend in the letters too but it is to issue guidance and issue on those kind of clarifications from CMS. Because I think the question really is what is the operating rule and what is supposed to be in it?
DR. WARREN: Any more questions? I am sure that there will be lots more questions but at least right now. Any more comments from people attending? Everyone is nodding their head no.
DR. SUAREZ: Just a quick comment. I want to thank Lorraine and the staff for the incredible work that have been done. You put together, I think it is just incredible the timing and the you know extent of complexity of the organization issues and being able to put it into such a nice coordinated way I think has been very helpful.
DR. WARREN: Lorraine has had to field all of the phone calls for people who want to testify, people who want to do it in a different time frame and who goes on what panels. She and her staff have managed which has just been wonderful because Walter and I have not had to deal with any of that which has been great.
This takes us down to our last topic which is we had some very clear ideas about where we need to go next but on the other hand we also need to kind of take charge of our own future and see where this Subcommittee would like to at least have a strategic plan for or work with. So what I did is a couple of years ago Harry started a PowerPoint template that really summarized everything about who our audiences were, who contributed to our agendas, what our process was, our outcomes and then looking at hot topics that we had to address immediately and then looking at those subjects we wanted to address. So I updated that slide and so everybody has a copy and then Walter’s task was to take a look at the future and where he saw things were happening which is on the second page. I got frustrated dealing with formatting on the power point and just added a second one.
With that, I think I am going to open it up for discussions. Is there anything that people know that is out there on the horizon that we need to get ready for, that we should take a voice on especially collaboration with the HIT Standards Committee because I don’t bark at a Walter, or divide the turf and use resources wisely or whatever those things are and then also Walter has these ideas on the back that he can speak to. So I will let Walter start first.
DR. SUAREZ: I think we know as Judy has just mentioned we know what we need to do in the next three, four, five months but there is a whole host of activity that we need to put in this sort of timeline into the next two, maybe three years at least and potentially you could go all the way to the next decade. Some of the important besides the fact of a ACA regulations on administration certification and the different elements that we need to include in there for not just later this year but next year as well the year what kind of timing is, there is a number of other topics that I think are going to become more and more important and where there is going to be a lot of more need to coordinate with Health IT Standards particularly.
So in the front side I think we added sort of this completion of planning to identify the operating rules at 5010 and ICD10 transition. Then on the back I included a series of additional topics that we should consider and evaluate the extent to which we will be involved. In many cases we will be heavily involved and it will be part of our responsibility by virtue of Affordability Care Act and in others it might be something that is important is coming up and it is something we should consider bringing into our agenda.
Let me briefly mention a few things about the topics. The very first one is on this back page is this topic on attachments let’s call it just generally and refer to it that way. So we now have in the Affordability of Care Act some expectation towards the back end of that timeline to 2014 or so that there will be a development of standards for claim attachments. Well interestingly enough the Health IT Standards Committee and one its work groups, clinical operations work group is also working on attachments from the perhaps other sides if there are two sides of it: the administrative side from claims or the clinical side. They were going to actually hold a hearing earlier this year. Interestingly enough we were preparing hearings back in early 2004 meaningful use came around and sort of took as in the meaningful use direction. So there is now an opportunity and there is at least some talk between the two committees, the leadership of the two committees having actually joint hearing on attachments, this is how we are referring to it.
MR. REYNOLDS: The two committees you are referring to are?
DR. SUAREZ: The two committees are really our Subcommittee, the Subcommittee on Standards and then the clinical operation work group of the Health IT Standards committee which is chaired by Jamie Ferguson. I am not a member of that work group but I being a member of the Health IT Standard Committee. We started talking to the leadership of the HIT Standards Committee, John Hillanka(?) and it is thrilling about this opportunity to doing actually a joint hearing on attachments involving the HIT Standards Committee with the operation work group on our Subcommittee here and they were thrilled with the idea. They thought it would be just terrific to do it. The topic would be perfect and the opportunity to begin to bring together the two fatheads would be just a terrific way of beginning to show that kind of increased coordination. So that is one topic that I think is going to be an important opportunity to consider over the next two months. The talk was probably lets plan to do something by the later part of the Fall just to begin to gather insights and input around this.
So that is one topic.
Of course there are other ones related to the standards where electronic fund transfer which under the schedule is supposed to have some regulations on January 1st of 2012. You find that will be a 2011 kind of timeline. The standard for electronic fund transfer that is one of the new standards required on the Accountability of Care Act and the date for the final rule is supposed to January 1st, 2012 so during 2011 there is going to be a need to develop input on the standard being selected.
There is this third bullet that I have here, all payer claims database. I don’t know how many people are familiar with this effort but this is an effort that has been growing across the country. Many states, at least eleven states have now state level, all payer claims database for purposes of policy monitoring, cost and quality studies and many other purposes. One of the critical elements that is missing from it is a standard for collecting. Believe it or not I actually have the legislation on several different states on this and some of the legislation in the states actually in the law itself, this is one of the first time I have seen it is, they actually identified data element by data element what is to be included in this all payer database systems. So it created a nightmare for many organizations that have to deal with those. Then there is a lack of an electronic standard for abrogating, putting together this data.
Usually this all payer data base system is a combination of the A35, the healthcare claim payment transaction that a health line generates and the A37, the inbound incoming A37 the administrative claims that are submitted prior to that so that would include a detailed utilization of services from the claim and the detailed actual payment from the payer side. Plus there is an eligibility component to it, an eligibility database that many states actually have created as well; standard eligibility databases.
So the opportunity is to look at establishing a standard for the electronic gathering of the combination of A35 and A37 and there is a number of groups that are pushing towards it but they do need sort of a national perspective around this and so that is why I thought of bringing it up to our Subcommittee because this is one of the places where this topic can be actually discussed. There have been a number of national forums and symposia and meetings, regional meetings. There is work being done on this topic but I think we would have a unique opportunity to convene something that could bring some consensus around how to proceed with this and help standardize this across the nation and help create an electronic standard for it.
DR. FERRER: Walter, I have a question. When you use the term attachment, are you referencing for example if I am sending a document, clinical document attachment perhaps might be sort of a parsing of that information for exchange. Is that? Okay.
DR. SUAREZ: It could be any of that. It could be that image.
DR. FERRER: Since we are talking a little bit about standards, standards conversations always tend to go into the content you know the actual content of the information. Blackford Middleton on meaningful use criteria when we held the hearing way back when, one of the things he recommended so I would begin to look at the standard of the forms for clinical care. For example he took Hexcel 1,500 forms. That is pretty standard in the industry, right? It is a form. What you put in it is differ-ability but the form itself is standardized right? But in clinical medicine when somebody says let me see the form for history and physical. Let me see the form for a progress note. Let me see the form for a post operative surgical node. There is no standards for that right because we want to standardize how people talk but the simply thing would be to actually standardize like you do in the Hexcel 1500. Is that something that you every think about or is that something that is just so out there that it is just inconceivable?
DR. SUAREZ: Well I think it is part of the discussions that the Health IT Standards Committee.
DR. FERRER: But I never hear them talk that way. I call into these calls at an HIT and for two years I have been hearing them talk. Nobody talks that way, right?
DR. SUAREZ: It is all around well if you have an electronic health record that should be capable of generating a CTV or CDA.
DR. FERRER: Right because we are still in the mindset of that attachment and so we build a lot of these but if we kind of said, well what about if you could just do the other one because as we evolve, part of it is education of also the HIT Standards Committee on kind of what is out there, right?
DR. SUAREZ: Exactly and then I think this is an opportunity that we have at this joint, this idea of having a joint session on what we would call attachments. It could be all sorts of different.
DR. FERRER: I think having two committees even talk to each other is a big deal so I think that is really good.
DR. CARR: Exercising stewardship of our resources, as I look at this very ambitious and lofty initiative, I wonder if you might think in terms of you know that need to have and the nice to have and separate out.
DR. SUAREZ: Sure, we were trying to bring as comprehensive list. We need to parse out this in two ways you know priorities and time. Some of these are things that must do but we must do it in not this year, not next month but during the coming.
DR. WARREN: Also in terms of the partnering of this to understand who would be doing the heavy lifting. On some things if we are participant verses thriving that be another way to think about it. We need to be cognizant of what is in our scope and what is on our plate.
DR. SUAREZ: Absolutely and we talked about it with Judy and some of this by partnering we could also benefit from some of the resources that the partner brings. They have IT standards committees and the resources they can bring into this.
I don’t think we intended to really go into detail, just a few examples. That is what I wanted to give but there is a longer list of all sorts of areas and probably more so. I just actually added a new board with Lorraine’s comment about the need to consider updates of the standards and some of these other expectations that the accountability of the part of our Subcommittee and to NCVHS to advise the Secretary on like three bullets from the bottom, the possible applicability of standards and operating rules to other industries like auto insurance, the healthcare component of auto insurance, Worker’s Comp and others and these other areas.
DR. WARRAN: I think you will find that the list is all granularities from very global things to very specific things. Some of these things are already on our template to at least ideas to develop. All we wanted to do here was to generate dialogue being fully cognizant that we just finished overwhelming everybody with what legislation is requiring of the committee, but some of these things are things that are already on our plate and we just want to get people’s feedback on what do you think of these ideas and then to do exactly the sort that Justine just mentioned of what are the nice to do’s if we had unlimited resources. What are the have to do’s that we see out here and with that Jeff, you have had your hand up so up to you.
MR. BLAIR: Walter, outstanding that you came up with a list. That is very useful. I haven’t been able to see it yet. Would you send that to me by the way? I think that is really neat. The other piece is Justine you said nice to have versus must have. Your suggestion that we begin to maybe do joint hearings with the HIT Standards Committee, I think that is also good heading down the right path.
I have the impression that maybe not this year but starting next year and the year after there may be so many areas of work to be done that it is really going to be difficult for both the HIT Standards Committee and NCVHS to deal with all of them. It might be a good idea to sit down and have a conversation either with Chuck Friedman or Blumenthal or John Blanca and Marc Overhage might be able to give us guidance on this because this probably is going to be other standards work that are not on that list yet which will emerge with this high urgent priority and be very disruptive to our planning next year and the year after and we may no longer have the luxury of doing joint meetings. It is going to be a matter of who is in the best position to do those evaluations and come up with thoughtful appropriate recommendations quickly. Anticipating that if you begin to have those conversations with ONC and CMS I think that that could ease the way for both the HIT Standards Committee and for us so that is my suggestion.
DR. WARREN: What I am wondering listening to Jeff and then I will turn it over to Justine is maybe what this list is, is a list of things we need to be aware of that are in the queue and as we do the high demand things we look to see whether or not that impacts or it influenced by anything on this list. That way we can do a two for.
DR. CARR: I think marrying it up with this grid that Walter has made that says here are all of the things on the table. Here is what NCVHS is doing, HIT Standards, HIT policy. I would also add IOM to that. Thinking about what are the parallel universes and then out of that coming to some structure around when it is outward facing this group does it. When it is inward facing this group does it or some sort of guiding direction so that we are not tripping over each other on some things and overlooking other things. So I think the dialogue among the FACAs is very good to get some sense on that. There may be things that we work on together but I think if we begin to understand what do we do best you know.
MR. BLAIR: Right because whoever has the best skills to be able to do this best because if element three is going to come down to the fact you mentioned IOM that is exactly what I was thinking of. In addition to what we already have with Health Reform putting things on our plate, element three may put some more things and some of them are synergistic, some of them are new, some of them really fit us because we have a quality committee and we have a privacy committee and we have all of these pieces so it may fit us best. Others may fit HIT Standards Committee best but I think that joint planning sessions anticipating these things could be helpful.
DR. CARR: I would also add because this is a personal experience on our meaningful measurement. As we were planning that committee we went back to the IOM performance measurement document and there were so many things well laid out that aligned with what we were finding that we probably could have done more due diligence in the beginning to build off that so this is your doing with the hearing this summer getting all of the education in advance. I think that is a great idea and I think again this document showing who else is working on it because I had actually already talked to Leslie about doing this in privacy and we need it in quality so that we are reading those documents and you know we came up with the stewardship thing too. We were working on data stewardship and ONC came out with their thing. So we want to be cognizant of not being redundant.
I really thank you for this. You know how much I like everything I have read.
MS. WILLIAMSON: Judy, I was looking at the list and I was thinking as you were going through Walter we only got to the first three. Just what dates might be associated with each of these if there is a date. For some there may not be. When you talked about standards like EFT you said they follow January 2012. Are there other dates associated with this that we should need to look at as we are trying to siphon and determine what needs to be.
DR. SUAREZ: There are dates for some of them. Some of the other ones are more open in terms of dates. Like specifically EFT has dates. Down the list there is improving electronic enrollment process which is not really a designated responsibility to NCVHS was specific to HIT Standards Committee. HIT Standards Committee of 400 enrollment work group but in that there is the need to look at enrollment electronic transaction standards which is a HIPAA standard, so it is important to make sure that we are at least involved or aware of it. That is moving very quickly, six months from the date so there are and my thought was once we have this listing we can put in a map that over the three or four years we can at least have a placeholder for these topics and we can add more topics and switch depending on ever year’s change in priorities based on new laws and new requirements.
MS. WILLIAMSON: That is immediately what I wanted to do is to take this list and say okay which do we need to look at first. What impact just where do we start.
DR. WARREN: To merge those with possible topics on the front slide and the hot topics. Hot topics were ones that we had deadlines on and we were assigned. Possible topics were those things that the committee wanted to work on so generating our own agenda, which has been sort of a tradition at NCVHS is for us to be out there looking five years down the road and trying to identify what is coming next.
DR. CARR: I think one of the things NCVHS does very well is to find the gaps. So by having this list it does not mean that we do the work but we say this is work that needs to be done, assigned so again it is very valuable.
DR. SUAREZ: The other thing is hopefully this will help us as we go into an executive retreat probably in September or sometime.
DR. WARREN: Okay so by my watch we have got somewhere around five minutes plus or minus three and I can’t see the clock on the wall.
DR. SUAREZ: That says 2:57.
DR. WARREN: Okay so you have three minutes. Anybody want to make closing comments about where we are, things that we have not had on the agenda that you thought were important?
Hearing none, I am going to give Jeff the last two minutes to make closing comments for posterity. We are starting the new decade without Jeff.
MR. BLAIR: Well you know I will tell you what I was thinking of actually and it was that I take a look at the membership right now on NCVHS and one thing is really clear to me is NCVHS continues to attract outstanding individuals to populate a full committee and a Subcommittee as we move forward. We continue to have earned the respect of Congress and the administrations that they come to us and when they write new major legislations, our name is in there in appropriate places. So I feel really, really proud of being part of NCVHS these last thirteen years and it looks to me as if the legacy, NCVHS is continuing to grow. So my applause to everybody here.
DR. FERRER: Can we make a proper comments about Jeff or not?
MS. TRUDEL: Yes you can make any kind of proper or improper comments you want.
DR. FERRER: I guess from a personal note, I met Jeff going back to twelve years now and I am not sure I know how to spell medical informatics twelve years ago and almost everything I learned in the first four years were almost a replica of Jeff: the way his mind thinking; concepts; standards. Had it not been for Jeff Blair, I would not even, I don’t know if it is a good thing or a bad thing but because then I have to live with the fact that Jeff educated me but very thankful for that because I think I speak on behalf of a lot of people in this space that met Jeff and a good person, too which you don’t see often times to get a good person in standards, those things don’t kind of mix usually well, but we are thankful and we appreciate it.
DR. WARREN: We should do a grid on when did you first meet Jeff because I first met Jeff at CPRI which people who remember CPRI was along time ago and that was when I was first getting into informatics and Jeff had tremendous patience because there was a lot of us in those early days who were not really sure why we were at the meeting that we told to go. He very patiently answered a lot of really dumb questions and got us started so thank you, Jeff.
MR. BLAIR: Thank you.
DR. WARREN: And we are adjourned. The next group starts right now.
(Whereupon, the subcommittee adjourned at 3:00 p.m.)